Sleep Management And Recovery After Traumatic Brain Injury in Kids: Pilot Intervention of Melatonin
Sleep Management And Recovery After Traumatic Brain Injury in Kids: Pilot Intervention of Melatonin
NCT ID: NCT04932096 Phase: PHASE2 Status: COMPLETED Enrollment: 21 Completion: 2025-03-01
Conditions
Traumatic Brain Injury, Critical Illness, Sleep
Interventions
melatonin, placebo
Summary
Sleep wake disturbances compound recovery in over half of pediatric traumatic brain injury survivors, leading to impaired quality of life, and few effective interventions exist to treat this important morbidity. Therefore, this study will conduct a randomized controlled trial evaluating a melatonin intervention started during hospitalization and continued after discharge compared to placebo. The trial will investigate if this intervention is feasible, acceptable, and effective at reducing sleep wake disturbances as measured on the Sleep Disturbances Scale for Children 1-month after hospital discharge.
Participants will be randomly assigned to receive the intervention (melatonin) or to the control group (placebo) with a goal of equal numbers of participants in each group and all will receive sleep education. Participants will be followed closely after consent and outcomes will be assessed at hospital discharge, and 1-month. Outcomes will focus on feasibility (ability to recruit patients into the trial) and acceptability (patient safety and satisfaction), but will also assess the effectiveness of the intervention to reduce sleep disturbances after discharge. The investigators will assess sleep using questionnaires and actigraphy (watch-like activity monitors). Exploratory outcomes will include global health outcomes.
Primary Outcome
Sleep Disturbances Scale for Children